Complementary Weaning With Adult Food Typical of the Mediterranean Diet
1 other identifier
interventional
394
0 countries
N/A
Brief Summary
A Randomized Controlled Clinical Trials was conducted to study the medium-long term impact of a complementary weaning using adult foods typical of Mediterranean Diets (MD) on children taste development and eating habits, and on the microbiota composition. Main objectives were to assess the effect of such weaning scheme on:
- 1.medium-long term adherence of the children to the MD (Primary aim).
- 2.familial eating habits to verify how many changes may come from an early education of the kid toward a Mediterranean eating style
- 3.the BMI of the children
- 4.gut microbiota composition
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2015
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedFirst Submitted
Initial submission to the registry
March 12, 2022
CompletedFirst Posted
Study publicly available on registry
March 28, 2022
CompletedMarch 28, 2022
March 1, 2022
1.2 years
March 12, 2022
March 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportions of children showing a good adherence (i.e. KidMed score >= 8) to Mediterranean diet
KidMed is a questionnaire measuring Mediterranean Diet Quality for children and adolescents. The final score ranges from from 0 to 12 where scores \>=8 indicates optimal Mediterranean diet; score within range 4-7 suggest that an improvement is needed to adjust intake to Mediterranean patterns and score \<=3 indicate very low diet quality.
36 months
Secondary Outcomes (4)
Average of the KidMed score
36 months
Average children's BMI
36 months
Proportion of overweight and obese children
36 months
Variation of microbial communities between arms based on Bray-Curtis dissimilarity
48 months
Study Arms (2)
Mediterranean Diet group
EXPERIMENTALControl group
NO INTERVENTIONInterventions
Kids in experimental group were weaned by using fresh foods traditionally used in MD and appropriately adapted to infants including seasonal fruit and vegetables, various kinds of fresh blue fish, spices and herbs. No salt was used while a small amount of Parmesan cheese was added. No sugar was added to any meal.
Eligibility Criteria
You may qualify if:
- Infants, either breast fed or formula fed between 4 and 6 months of age
- Informed consent from at least one parent
You may not qualify if:
- Infants either with associated comorbidities or with low birth weight
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
de Franchis R, Bozza L, Cortese P, D'Antonio L, D'Avino A, Gasparini N, Ippolito G, Spadaro R, Tedesco M, Antignani A, De Filippis F, Valentino V, Auricchio R, Auricchio S, Bruzzese D. Can Early Nutrition Be Responsible for Future Gut Microbiota Changes and Different Health Outcomes? Nutrients. 2025 Nov 27;17(23):3721. doi: 10.3390/nu17233721.
PMID: 41374011DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Full Professor
Study Record Dates
First Submitted
March 12, 2022
First Posted
March 28, 2022
Study Start
May 1, 2015
Primary Completion
July 1, 2016
Study Completion
December 31, 2019
Last Updated
March 28, 2022
Record last verified: 2022-03